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Evaluation of vitamin D effect on duration of mechanical ventilation and Total Antioxidant Capacity (TAC) in ICU admitted patients

Protocol summary

Study aim
Evaluation of vitamin D effect on duration of mechanical ventilation, mortality rate (SOFA score) and respiratory infection rate
Design
Two arm parallel groups randomized trial (control and intervention groups), blinded and outcome assessment
Settings and conduct
Ventilated ICU patients of Imam Hussein hospital in Tehran will be divided into intervention and control groups and will be evaluated
Participants/Inclusion and exclusion criteria
Inclusion criteria: ICU admitted patients equal or over 18 years old, Mechanically ventilated patients, Patients expected to be alive until 96 hours after ICU admission Exclusion criteria: Dissatisfaction of patient's legal guardian, Pregnancy, MAP<60 after three consecutive measurement before inclusion, Ca>10.8, High dose vitamin D treatment, Hypercalcemia related diseases, Cirrhotic and HIV infected patients
Intervention groups
Intervention group: ICU ventilated patients receiving 300000 IU of Intramuscular vitamin D3 Control group: ICU ventilated patients receiving intramuscular placebo
Main outcome variables
Serum TAC (total antioxidant capacity) level; CPIS(Clinical Pulmonary Infection Score); SOFA score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120703010178N16
Registration date: 2018-06-25, 1397/04/04
Registration timing: registered_while_recruiting

Last update: 2018-06-25, 1397/04/04
Update count: 0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D effect on duration of mechanical ventilation and Total Antioxidant Capacity (TAC) in ICU admitted patients
Public title
Effect of vitamin D on duration of mechanical ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ICU admitted patients equal or over 18 years old Mechanically ventilated patients Patients expected to be alive until 96 hours after ICU admission
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method by Random function of Excel software
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researcher will be blind to this study and placebo or drug (as group A or B) will be given to the patient by use of randomization table
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
1397.12.IR.SBMU.PHNM

Health conditions studied

1

Description of health condition studied
Mechanically ventilated patients in the intensive care unit
ICD-10 code
J00-J99
ICD-10 code description
Diseases of the respiratory system

Primary outcomes

1

Description
25-Hydroxy vitamin D level
Timepoint
Day 0 and 7
Method of measurement
Blood 25-hydroxy vitamin D measurement

Secondary outcomes

1

Description
Total Antioxidant Capacity (TAC) level
Timepoint
Day 0 and 7
Method of measurement
Total Antioxidant Capacity kit

2

Description
Duration of mechanical ventilation in intensive care unit
Timepoint
Daily
Method of measurement
Counting mechanical ventilator connection days

3

Description
Drug effect on rate of respiratory infection
Timepoint
Daily until 7 days and on day 14 and 28
Method of measurement
CPIS (Clinical Pulmonary Infection Score)

4

Description
Mortality
Timepoint
Daily until 7 days and on day 14 and 28
Method of measurement
Sequential Organ Failure Assessment score

Intervention groups

1

Description
Intervention group: Receiving 300000 international unit of intramuscular vitamin D by DARUPAKHSH manufacture in day 0
Category
Treatment - Drugs

2

Description
Control group: Patients receiving intramuscular placebo by DARUPAKHSH manufacture in day 0
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Intensive care unit, Imam Hussein medical center
Full name of responsible person
Mohammad Sistanizad
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0087
Email
sistanizadm@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 23 87121
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor, Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0087
Email
sistanizadm@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor, Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218820087
Email
sistanizadm@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Moeini Vasegh
Position
Pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-asr St,Niayesh
City
Tehran
Province
Tehran
Postal code
3371875158
Phone
+98 21 3622 5790
Email
fatemeh.moein72@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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